Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy and Safety of Neoadjuvant Treatment With Tislelizumab (BGB-A317, Anti-PD-1 Antibody) or Placebo Plus Platinum-Based Doublet Chemotherapy Followed By Adjuvant Tislelizumab or Placebo in Resectable Stage II or IIIA Non-Small Cell Lung Cancer
2 other identifiers
interventional
453
1 country
44
Brief Summary
The primary objective of this study is to evaluate and compare major pathological response(MPR) rate and event-free survival (EFS) in participants receiving tislelizumab plus platinum-based doublet chemotherapy as the new additional treatment followed by tislelizumab as adjuvant treatment versus participants receiving placebo plus platinum-based doublet chemotherapy as neoadjuvant treatment followed by placebo as adjuvant treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2020
Longer than P75 for phase_3
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2020
CompletedFirst Posted
Study publicly available on registry
May 7, 2020
CompletedStudy Start
First participant enrolled
May 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
ExpectedMarch 18, 2026
March 1, 2026
3.2 years
May 4, 2020
March 17, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Major pathological response (MPR) in Intent-to-Treat (ITT) analysis set
Up to 3 months following completion of neoadjuvant treatment
Event-free survival (EFS) in ITT analysis set as Assessed by the Blinded Independent Central Review (BICR)
Up to 5 years
Secondary Outcomes (7)
Overall survival (OS) in the ITT set
Up to 5 years
Pathological complete response (pCR) rate
Up to 5 years
Objective Response Rate (ORR)
Up to 5 years
Disease-Free Survival (DFS) in ITT analysis set
Up to 5 years
Event-free survival (EFS) Assessed by the Investigator
Up to 5 years
- +2 more secondary outcomes
Study Arms (2)
Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab
EXPERIMENTALTislelizumab + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium
Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo
PLACEBO COMPARATORPlacebo + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium
Interventions
administered via IV infusion
administered via IV infusion
administered via IV infusion
Placebo to match tislelizumab IV infusion
administered via Intravenous (IV) injection
administered via IV infusion
Eligibility Criteria
You may qualify if:
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Histologically confirmed Stage II or IIIA NSCLC
- Measurable disease as assessed per RECIST v1.1
- Confirm eligibility for an R0 resection with curative intent
You may not qualify if:
- Any prior therapy for current lung cancer, including chemotherapy, or radiotherapy
- Known Epidermal growth factor receptor (EGFR) mutation or Anaplastic Lymphoma Kinase (ALK) gene translocation
- Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before randomization
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (44)
Anhui Provincial Hospital
Hefei, Anhui, 230000, China
Peking University Peoples Hospital
Beijing, Beijing Municipality, 100044, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Quanzhou First Affliated Hospital of Fujian Medical University
Quanzhou, Fujian, 362000, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, 510030, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Jiangmen Central Hospital
Jiangmen, Guangdong, 529030, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515031, China
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, 530021, China
Hainan Cancer Hospital
Haikou, Hainan, 570312, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
Luoyang Central Hospital
Luoyang, Henan, 471009, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, 330006, China
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang, Jiangxi, 332000, China
Jilin Cancer Hospital
Changchun, Jilin, 130021, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030000, China
Sichuan Cancer Hospital and Institute
Chengdu, Sichuan, 610041, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650100, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No2 Hospital)
Ningbo, Zhejiang, 315000, China
Related Publications (2)
Wang C, Wang W, Liu H, Chen Q, Chen C, Liu L, Zhang P, Zhao G, Yang F, Han G, Yu B, Yang Y, Chen H, Jiang J, Tan L, Xu S, Mao N, Hu J, Zhang L, Zhang Z, Yao B, Wang S, Leaw S, Naicker K, Zheng W, Yu C, Yue D; RATIONALE-315 investigators. Perioperative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non-small-cell lung cancer: final analysis of the randomized RATIONALE-315 trial. Ann Oncol. 2026 Apr;37(4):544-554. doi: 10.1016/j.annonc.2025.11.017. Epub 2025 Dec 2.
PMID: 41344593DERIVEDYue D, Wang W, Liu H, Chen Q, Chen C, Liu L, Zhang P, Zhao G, Yang F, Han G, Cheng Y, Yu B, Yang Y, Chen H, Jiang J, Tan L, Xu S, Mao N, Hu J, Zhang L, Yao B, Wang S, Wang RH, Zheng W, Wang C; RATIONALE-315 investigators. Perioperative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non-small-cell lung cancer (RATIONALE-315): an interim analysis of a randomised clinical trial. Lancet Respir Med. 2025 Feb;13(2):119-129. doi: 10.1016/S2213-2600(24)00269-8. Epub 2024 Nov 21.
PMID: 39581197DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
BeiGene
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2020
First Posted
May 7, 2020
Study Start
May 29, 2020
Primary Completion
August 21, 2023
Study Completion (Estimated)
March 31, 2027
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.